Manual Wheelchairs with Transit System Option, Model: Quickie LXI (EILXI), Product is manufactured and distributed by Sunrise Medical, Inc. Fresno, CA Intended to provide mobility to persons restricted to a sitting position and are unable to transfer from their wheelchairs when traveling in motor vehicles, the wheelchair must serve as a vehicle seat.
FDA Recall Z-0831-2011 · Posted 2010-12-28
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Recalling FirmSunrise Medical Inc
Recall StatusTerminated
Product CodeIOR
Date Initiated2009-02-02
Date Terminated2011-01-03
Product Quantity23
Reason for Recall
The stabilizer bar was inadvertently omitted during the manufacturing process.
Firm Action
An Urgent: Medical Device Correction letter, dated February 2009, with certified return receipt was sent to customers in the United States; Canadian consignees were notified via e-mail. The letter identified the affected product and the reason for the recall. The letters asked customers to contact their Quickie dealer to make arrangements to have their device wheelchair corrected at no charge and to also verify their wheelchair serial number on the form. Questions should be directed towards their dealer or Sunrise Medical at 800-456-8168.
Root Cause
Process change control
Distribution Pattern
Worldwide Distribution -- United States and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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